Rather than rely on manufacturers to tell us how many times we may use their products, should we not be testing these items after each use? Although the manufacturer recommends that we only use an item 40 times, how do we know that it is safe after the first use? I think that we should be testing, but I welcome any comments and ideas.

Dave Hewitt

Dear Dave,

Indeed we do not know for certain if a medical device is still safe after it's first use. But the obligations of the manufacturer are clearly described in Annex I, Essential requirements, Medical Device Directive, 93/42/EEC.
Clause 1 says: The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients etc....
Clause 13 says that where appropriate, the instructions for use must contain the following particulars:
(h) If the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and where appropriate, the method of sterilization of the device to be resterilized, and any restriction on the number of reuses.

Therefor we have to rely on and trust the manufacturer. It is his responsability to deliver a medical device that meets the requirements and does what it is supposed to do. In all cases he will build in a safety margin in his concept. Also he will be aware of the serious legal and financial consequences of product liability.

In our department we are glad that we could end the reuse of single use devices. It is not possible - and unnecessary - for us to check the functionality of all reusable electrical equipment.

Kind regards,
Wim Renders